Tobacco consumption (smoking)
Conditions
Interventions
Group 1: Participation in a digital smoking cessation intervention consisting of nicotine cessation via e-cigarette and app-based behavioural therapy.
Sponsors
Institut für Integrative Gesundheitsversorgung und Gesundheitsförderung (IGVF)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - smoking cigarettes for at least 12 months, at least 5 cigarettes per day, - motivation to stop smoking (Motivation To Stop Scale (MTSS; (41)) > 4 points), - daily access to own smartphone (iOS 15/Android 11 or newer) - resident in Germany, - access to a personal email account, - sufficient German language skills, written and spoken
Exclusion criteria
Exclusion criteria: - pregnancy/breastfeeding or intention to become pregnant during the study period, - allergy to vegetable glycerol or propylene glycol, - drug and/or alcohol dependence, - severe psychiatric or physical illness or disease that is a contraindication to the use of e-cigarettes, - taking medication that could affect the results of the study or is a contraindication to the use of e-cigarettes (bupropion/nortriptyline/varenicline/cytisine/clonidine/antidepressants), - surgical procedure in the last 6 weeks (with anaesthesia), - participation in another smoking cessation programme, - use of e-cigarettes/tobacco heaters/alternative tobacco products/nicotine replacement therapy for more than 5 days in the last 30 days. - no consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported 7-day point prevalence abstinence (PPA) from cigarette smoking. Measurement time points: Baseline (t0), after 4 weeks (t1), after 8 weeks (t2), after 12 weeks (t3), after 24 weeks (t4) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage reduction in cigarettes smoked per day - 30-days PPA - Repeated PPA - Continuous PPA (< 5 cigarettes since target quit date) - Urges to smoke (VRS v4-1) - Perceived stress (Perceived Stress Scale; PSS-10) - Mindfulness (Freiburg Mindfulness Inventory short version; FFA) - Smoking self-efficacy (“How confident are you that you will be completely abstinent from smoking cigarettes in one year from now? (1 “not confident at all” -10 “very confident”), Smoking Self-Efficacy Questionnaire; SEQ-12) - Subjective health (Short Form Health Survey; SF-12) - Life satisfaction (L-1) Measurement time points: Baseline (t0), after 4 weeks (t1), after 8 weeks (t2), after 12 weeks (t3), after 24 weeks (t4) | — |
Countries
Germany
Contacts
Public ContactHelen Schiek
Institut für Integrative Gesundheitsversorgung und Gesundheitsförderung (IGVF)
Outcome results
None listed